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Vyvanse(R) (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved
in the US for Maintenance Treatment in Adults with ADHD
PHILADELPHIA, February 7, 2012 /PRNewswire/ --
?Vyvanse (lisdexamfetamine dimesylate), an
approved treatment forAttention-Deficit/Hyperactivity Disorder
(ADHD) in patients ages 6 and above, is the first
medication both proven to work and approved for maintenance treatment
in adults with ADHD
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that the US Food and Drug
Administration (FDA) approved the prescription medication Vyvanse@
(lisdexamfetamine dimesylate) Capsules, (CII) as a maintenance
treatment for adults with ADHD. The approval is based on results from
a randomized withdrawal study designed to evaluate the efficacy of
Vyvanse in adults (aged 18 to 55 years) who were receiving treatment
with Vyvanse for a minimum of 6 months prior to enrolling in the
study. Significantly more patients treated with Vyvanse maintained
ADHD symptom control compared with placebo as determined by the
proportion of patients who met criteria for relapse of symptoms at end
point during the six-week randomized double-blind withdrawal phase of
the study (8.9% of Vyvanse-treated patients vs 75% for placebo). This
new approval adds to the indication for Vyvanse as a treatment for
ADHD in patients ages 6 and above.
Vyvanse should be used as part of a total treatment program that may
include counseling or other therapies. The physician who elects to use
Vyvanse for extended periods should periodically reevaluate the
long-term usefulness of the drug for the individual patient.
In a randomized withdrawal design, patients who respond to a treatment
are randomized to continue receiving that treatment or placebo.
Utilizing the proportion of patients experiencing symptom relapse as a
primary outcome, this type of study in patients with ADHD can be used
to demonstrate long-term efficacy in lieu of conducting a long-term
placebo-controlled, parallel-group study. The utility of this design
is that the period of placebo exposure, with the potential for
worsening of ADHD symptoms, is relatively short. "Data from this study
and the resulting approval illustrate that Vyvanse can help adults
with ADHD maintain symptom control. Vyvanse is the first medicine both
proven to work and approved to maintain efficacy in adults with ADHD"
said Jeffrey Jonas, MD, Senior Vice President of Research and
Development for Shire's Specialty Pharmaceuticals and Regenerative
Medicine businesses. "This underscores Shire's commitment to providing
important advances in the treatment of individuals with ADHD by
investing in innovative research in this area," added Dr. Jonas.
Vyvanse is a Schedule II controlled substance. Stimulants, such as
amphetamines and methylphenidates, are subject to misuse, abuse,
addiction, and criminal diversion. Misuse of amphetamines may cause
sudden death and serious cardiovascular adverse events.
This Phase 4, double-blind, multi-center, placebo-controlled,
randomized withdrawal design study assessed the maintenance of
efficacy and safety of Vyvanse in 123 adults who met DSM-IV-TR@
criteria for ADHD. Prior to enrollment, patients were required to have
documented long-term treatment with Vyvanse (30, 50, or 70 mg/day) for
at least 6 months and demonstrated treatment response as defined by an
ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts total score of
<22 and Clinical Global Impressions-Severity (CGI-S) ratings <3. After
screening, eligible patients entered a three-week open-label treatment
phase in which they continued to receive the same Vyvanse dose they
were taking at study entry. Following this open-label treatment,
patients who maintained treatment response at week 3 entered the
six-week double-blind, randomized withdrawal phase (n116), in which
they received on-going treatment with the same dose of Vyvanse (n56),
or switched to placebo (n60). The ADHD-RS-IV with adult prompts is a
clinician assessment of the severity of the core symptoms of ADHD. The
CGI-S is a clinician assessment of symptom severity.
The primary efficacy outcome measure was the proportion of patients
who met criteria for relapse of ADHD symptoms at end point during the
double-blind, randomized withdrawal phase. End point was defined as
the last post-randomization treatment week at which a valid ADHD-RS
with adult prompts total score and CGI-S were observed. Relapse of
ADHD symptoms was defined as a ?50% increase (worsening) in the
ADHD-RS-IV with adult prompts total score and a ?2-point increase in
the CGI-S score compared to scores at entry into the double-blind
randomized withdrawal phase. Patients who met criteria for relapse of
ADHD symptoms were immediately discontinued from the study.
On the primary efficacy measure, significantly fewer patients met
criteria for symptom relapse with Vyvanse (8.9 versus placebo (75%)
(P<.0001) at end point of the randomized withdrawal phase. The
majority (approximately 62 of placebo treated patients who met
criteria for relapse of ADHD symptoms did so within 2 weeks following
randomization.
During the open-label phase, seven patients discontinued from the
study, including one patient on Vyvanse who discontinued due to a
treatment-emergent adverse event (TEAE) (lack of efficacy). One
serious adverse event (SAE) was reported during the randomized
withdrawal phase in a patient receiving placebo (suicidal ideation).
No SAEs were reported in patients receiving Vyvanse, and no deaths
were reported. During the randomized withdrawal phase, 48.2% (27/56)
of patients receiving Vyvanse and 30% (18/60) on placebo reported
TEAEs. The most common (?2 TEAEs reported in the Vyvanse treatment
group included headache, upper respiratory tract infection, insomnia,
fatigue and joint sprain. Mean systolic and diastolic blood pressure
and pulse rate were slightly higher for Vyvanse-treated patients
compared to placebo-treated patients. Small changes in mean blood
pressure and pulse rate were observed from baseline to week 3 in the
open-label phase and at end point of the randomized withdrawal phase
for both Vyvanse and placebo treatment groups. The safety profile seen
in this study was consistent with that of other studies of Vyvanse. No
new clinically relevant safety signals were associated with abrupt
discontinuation of Vyvanse.
"The finding from this study is important because adult patients with
ADHD may have a need for extended treatment, and could benefit from a
treatment option proven to maintain efficacy," stated Matthew Brams,
MD, Principal Investigator and Clinical Assistant Professor of
Psychiatry at Baylor College of Medicine. "This study showed that in
patients with ADHD who were stable on Vyvanse for 6 months, 91%
randomized to receive Vyvanse continued to maintain symptom control
compared with 25% taking placebo."
ABOUT VYVANSE (lisdexamfetamine dimesylate)
Vyvanse, which was introduced in the United States in July 2007 for
the treatment of ADHD in children ages 6 to 12 years, approved in
April 2008 to treat ADHD in adults, and approved in November 2010 to
treat ADHD in adolescents ages 13 to 17, is currently available in six
once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and
70 mg.
Additional information about Vyvanse is available at
INDICATION
Vyvanse is indicated for the treatment of ADHD in patients ages 6 and
above as part of a total treatment plan that may include other
measures (psychological, educational, social). Efficacy was
established in short-term controlled studies in children aged 6 to 17
and adults. Vyvanse is also approved as a maintenance treatment for
adults with ADHD based on one randomized withdrawal study. Extended
use of Vyvanse should be periodically reevaluated to determine its
long-term usefulness for the individual patient.
IMPORTANT SAFETY INFORMATION
WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION
See Full Prescribing Information for complete Boxed WARNING.
. Vyvanse is a Schedule II controlled substance. Stimulants, such as
amphetamines and methylphenidates, are subject to misuse, abuse,
addiction, and criminal diversion.
. Misuse of amphetamines may cause sudden death and serious
cardiovascular adverse events.
. Contraindications: Known hypersensitivity to amphetamines or other
ingredients in Vyvanse. Anaphylactic reactions, Stevens-Johnson
Syndrome, angioedema, and urticaria have been observed in
postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors
(MAOIs) can result in hypertensive crisis. Stop MAOIs at least 14 days
prior to Vyvanse use.
. Sudden death, stroke and myocardial infarction have been reported
with stimulants at usual doses for the treatment of ADHD. Stimulants
generally should not be used in patients with known structural cardiac
abnormalities or other serious heart problems. Adults have a greater
likelihood than children of having such cardiac disease. Patients
being considered for stimulant treatment should have a careful history
(including family history of sudden death or ventricular arrhythmia)
and physical exam to assess for the presence of cardiac disease.
Further evaluation should be conducted if needed (eg,
electrocardiogram and echocardiogram). Patients who develop symptoms
suggestive of cardiac disease (eg, exertional chest pain, unexplained
syncope) during stimulant treatment should undergo a prompt
evaluation.
. Use with caution in patients whose underlying medical condition
might be compromised by increases in blood pressure or heart rate.
Stimulants cause modest increases in average blood pressure (about 2-4
mmHg) and average heart rate (about 3-6 bpm) and patients may have
larger increases. Monitor all patients for larger changes.
. Use of stimulants may cause psychotic or manic symptoms in patients
with no prior history, or exacerbation of symptoms in patients with
pre-existing psychosis. Clinical evaluation for bipolar disorder is
recommended prior to stimulant use. Monitor for aggressive behavior.
. Monitor growth in children during treatment with Vyvanse. Children
who are not growing (gaining height or weight) as expected may need to
have their treatment interrupted.
. Stimulants may lower the convulsive threshold. Discontinue if
seizures develop.
. Visual disturbances and exacerbation of tics and Tourette's syndrome
have been reported with stimulant treatment.
. The most common adverse reactions (?5% and at least twice the rate
of placebo) reported in clinical trials were:
-- Children aged 6 to 12: decreased appetite, insomnia, upper
abdominal pain, irritability, decreased weight, vomiting, nausea,
dizziness and dry mouth;
-- Adolescents aged 13 to 17: decreased appetite, insomnia, and
decreased weight;
-- Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea,
anxiety and anorexia.
Please click here for Full Prescribing Inform a t ion for Vyvanse
(lisdexamfetamine dimesylate), including Boxed WARNING regarding
Potential for Misuse, Abuse, Addiction, and Diversion.
ABOUT ADHD
Attention-Deficit/Hyperactivity Disorder is a neurobehavioral disorder
that manifests as a persistent pattern of inattention and/or
hyperactivity-impulsivity and is more frequent and severe than is
typically observed in individuals at a comparable level of
development.
ADHD is one of the most common childhood psychiatric disorders.
Although many people tend to think of ADHD as a childhood problem, 60%
to 85% of children with ADHD may continue to meet the criteria for the
disorder during their teenage years. Nearly 50% of children with ADHD
may continue to meet the criteria for the disorder into adulthood,
based on parent-report. The disorder is estimated to affect 4.4
percent of US adults aged 18 to 44 based on results from the National
Comorbidity Survey Replication. When this percentage is extrapolated
to the full US population aged 18 and over, approximately 10 million
adults are estimated to have ADHD.
The specific etiology of ADHD is unknown, and there is no single
diagnostic test for this disorder. Adequate diagnosis requires the use
of medical and special psychological, educational, and social
resources, utilizing diagnostic criteria specified in the Diagnostic
and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
(DSM-IV-TR@) or International Classification of Diseases, 10th
revision (ICD-10).
Although there is no cure for ADHD, there are accepted treatments that
have been demonstrated to improve symptoms. Standard treatments
include educational approaches, psychological therapies which may
include behavioral modification, and/or medication. Ongoing assessment
and treatment may be necessary.
Notes to editors
SHIRE PLC
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician. Shire focuses its business on attention deficit
hyperactivity disorder, human genetic therapies, gastrointestinal
diseases and regenerative medicine as well as opportunities in other
therapeutic areas to the extent they arise through acquisitions.
Shire's in-licensing, merger and acquisition efforts are focused on
products in specialist markets with strong intellectual property
protection and global rights. Shire believes that a carefully
selected and balanced portfolio of products with strategically aligned
and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a
number of risks and uncertainties and are subject to change at any
time. In the event such risks or uncertainties materialize, the
Company's results could be materially adversely affected. The risks
and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative
Medicine products, as well as the ability to secure new products for
commercialization and/or development; government regulation of the
Company's products; the Company's ability to manufacture its products
in sufficient quantities to meet demand; the impact of competitive
therapies on the Company's products; the Company's ability to
register, maintain and enforce patents and other intellectual property
rights relating to its products; the Company's ability to obtain and
maintain government and other third-party reimbursement for its
products; and other risks and uncertainties detailed from time to time
in the Company's filings with the Securities and Exchange Commission.
For further information please contact:
Investor Relations Eric Rojas, erojas@shire.com,
+1-781-482-0999 Sarah Elton-Farr, seltonfarr@shire.com,
+44-1256-894157
Media Jessica Mann (Corporate),
jmann@shire.com, +44-1256-894-280 Gwen Fisher (Specialty Pharma),
gfisher@shire.com, +1-484-595-9836
SOURCE Shire plc
-0- 02/07/2012
(NASDAQ-NMS:SHPGY /
RICS:SHP.L /
RICS:SHPGY.O /
LSE:SHP) /
CO: Shire plc
ST: United States of America
IN: MTC MEQ
SU: FDA TRI
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